Advanced Solid Tumors
Conditions
Keywords
Phase I/II, BLZ945, PDR001, CSF-1R, PD-1, advanced solid tumors, glioblastoma
Brief summary
The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in combination with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent or in combination with PDR001, administered intravenously (i.v.) in adult patients with advanced solid tumors.
Detailed description
This study was a first in human, open-label, multi-center phase I/II study which consisted of a phase I dose escalation part of BLZ945 as single agent, and of BLZ945 in combination with PDR001, where alternative dosing regimens of BLZ945 were evaluated. The escalation was guided by a Bayesian logistic regression model with overdose control. Once the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) for BLZ945 as single agent was established, a phase II part could commence, should signs of antitumor activity had been seen during the phase I. Once the MTD/RP2D for BLZ945 in combination with PDR001 was established, a phase II part could commence. Phase I part of the study involved patients with advanced solid tumors, including patients with recurrent glioblastoma and patients with Hodgkin's lymphoma, and phase II part patients with relapsed or refractory glioblastoma. A separate Japanese single agent dose escalation was performed in order to ensure that the safety and pharmacokinetic profiles of BLZ945 single agent were adequately characterized in Japanese patients. The Japanese dose escalation for BLZ945 single agent run separately from the ongoing global dose escalation. No Japanese patients were enrolled in phase II part according to protocol. The enrollment of the Japanese cohort was halted per investigator letter, dated 18-Jun-2021.
Interventions
DRUGBLZ945
BLZ945 administered orally as a capsule. Up to five alternative dosing schedules were evaluated: once per day (QD) 7 days on/7 days off (i.e., administer BLZ945 for 7 days and suspend for 7 days), QD 4 days on/10 days off, twice per day (BID) 4 days on/10 days off, once weekly (Q1W) QD and Q1W BID. Each cycle consisted of 28 days.
DRUGPDR001
PDR001 400 mg administered via intravenous (i.v.) infusion every 4 weeks (Q4W)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Phase I: Patients with advanced/metastatic solid tumors including relapsed or refractory (r/r) glioblastoma and r/r lymphoma, with measurable or unmeasurable disease as determined by the respective response evaluation criteria. 2. Phase I: Patients with a site of disease amenable to biopsy, and willing to undergo a new tumor biopsy at screening, and during treatment. 3. Phase II: Patients with advanced/metastatic/recurrent isocitrate dehydrogenase (IDH) wild-type glioblastoma, with at least one measurable lesion as determined by RANO
Exclusion criteria
1. History of severe hypersensitivity reactions to monoclonal antibodies. 2. Impaired cardiac function or clinically significant cardiac disease. 3. Active autoimmune disease or a documented history of autoimmune disease. 4. Systemic steroid therapy or any immunosuppressive therapy 5. Use of any vaccines against infectious diseases within 4 weeks of initiation of study treatment. 6. Patient receiving treatment with medications that either strong inducers or inhibitors of CYP2C8 or CYP3A4/5, or patients receiving medication that prohibits proton pump inhibitors and that cannot be discontinued at least 1 week prior to start of treatment and for the duration of the study. 7. Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the prior 2 weeks before start of study treatment (not applicable for glioblastoma).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | From first dose of study medication up to 30 days after last dose, with a maximum duration of 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration. |
| Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | From first dose of study medication up to last dose, with a maximum duration of 3 years for BLZ945 single agent and 4 years for BLZ945 in combination with PDR001 | Number of participants with at least one dose reduction of BLZ945 and number of participants with at least one dose interruption of BLZ945. |
| Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | From first dose of study medication up to last dose, with a maximum duration of 4 years | Number of participants with at least one dose reduction of PDR001 and number of participants with at least one dose interruption of PDR001. Dose reductions were not permitted for PDR001. |
| Phase I: Dose Intensity of BLZ945 | From first dose of study medication up to last dose, with a maximum duration of 3 years for BLZ945 single agent and 4 years for BLZ945 in combination with PDR001 | Dose intensity of BLZ945 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 7 days out of every 14 in the 7 days on/7 days off regimen, 4 days out of every 14 in the 4 days on/10 days off regimen and 1 day out of every 7 in the Q1W regimen. |
| Phase I: Dose Intensity of PDR001 | From first dose of study medication up to last dose, with a maximum duration of 4 years | Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 1 day out of every 28 in the Q4W regimen. |
| Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 28 days | A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with BLZ945 as single agent or in combination with PDR001 during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. |
| Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Japanese Cohort) | 28 days | A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with BLZ945 as single agent or in combination with PDR001 during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. |
| Phase II: Progression-Free Survival Rate at 6 Months (PFS6) Per RANO Criteria for Glioblastoma | 6 months | PFS rate represents the percentage of participants without a first documented progression or death due to any cause after the start of study treatment. Tumor response was based on local investigator assessment per Response Assessment in Neuro Oncology (RANO) criteria. PFS was analyzed using Kaplan-Meier estimates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | From start of treatment until disease progression, assessed up to 4.1 years in Phase I and 1.4 years in Phase II | BOR is defined as the best response recorded from the start of the study treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started), based on local investigator assessment per RANO criteria. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. If a response recorded at one scheduled magnetic resonance imaging (MRI) did not persist at the next regular scheduled MRI, the response was recorded based on the prior scan, but was designated as a non-sustained response. If the response was sustained, i.e. still present on the subsequent MRI, it was recorded as a sustained response, lasting until the time of tumor progression. CR and PR had to be confirmed by repeat assessments performed not less than 4 weeks after the criteria for response were first met. |
| Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | From start of treatment until disease progression, assessed up to 4.1 years in Phase I and 1.4 years in Phase II | BOR is defined as the best response recorded from the start of the study treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started), based on local investigator assessment per iRANO. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. If a response recorded at one scheduled magnetic resonance imaging (MRI) did not persist at the next regular scheduled MRI, the response was recorded based on the prior scan, but was designated as a non-sustained response. If the response was sustained, i.e. still present on the subsequent MRI, it was recorded as a sustained response, lasting until the time of tumor progression. CR and PR had to be confirmed by repeat assessments performed not less than 4 weeks after the criteria for response were first met. Additionally, for iRANO, progressive disease had to be confirmed. |
| Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | From start of treatment until disease progression, assessed up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. |
| Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1. |
| Phase I: Overall Response Rate (ORR) Per irRC | Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | ORR is the percentage of patients with a best overall response of complete response (irCR) or partial response (irPR), based on local investigator assessment per irRC. |
| Phase I: Overall Response Rate (ORR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies. |
| Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per RECIST v1.1. |
| Phase I: Disease Control Rate (DCR) Per irRC | Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | DCR is the percentage of patients with a best overall response of complete response (irCR), partial response (irPR) or stable disease (irSD), based on local investigator assessment per irRC. |
| Phase I and II: Disease Control Rate (DCR) Per iRANO | Up to 4.1 years in Phase I and 1.4 years in Phase II | DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per iRANO criteria. |
| Phase I: Disease Control Rate (DCR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies. |
| Phase II: Duration of Response (DOR) Per RANO | Up to 1.4 years for BLZ945 single agent and 0.6 years for BLZ945 in combination with PDR001 | DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RANO. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. |
| Phase II: Duration of Response (DOR) Per iRANO | Up to 1.4 years for BLZ945 single agent and 0.6 years for BLZ945 in combination with PDR001 | DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per iRANO. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. |
| Phase II: Overall Survival (OS) | From start of treatment until death due to any cause, assessed up to 1.9 years for BLZ945 single agent and 1.3 years for BLZ945 in combination with PDR001 | OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, OS time was censored at the date of last contact. OS was estimated using Kaplan-Meier estimates. |
| Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | From first dose of study medication up to 30 days after last dose, with a maximum duration of 1.4 years for BLZ945 single agent and 0.6 years for BLZ945 in combination with PDR001 | Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration. |
| Phase II: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | From first dose of study medication up to last dose, with a maximum duration of 1.3 years for BLZ945 single agent and 0.5 years for BLZ945 in combination with PDR001 | Number of participants with at least one dose reduction of BLZ945 and number of participants with at least one dose interruption of BLZ945. |
| Phase II: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | From first dose of study medication up to last dose, with a maximum duration of 0.5 years | Number of participants with at least one dose reduction of PDR001 and number of participants with at least one dose interruption of PDR001. Dose reductions were not permitted for PDR001. |
| Phase II: Dose Intensity of BLZ945 | From first dose of study medication up to last dose, with a maximum duration of 1.3 years for BLZ945 single agent and 0.5 years for BLZ945 in combination with PDR001 | Dose intensity of BLZ945 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 4 days out of every 14 in the 4 days on/10 days off regimen. |
| Phase II: Dose Intensity of PDR001 | From first dose of study medication up to last dose, with a maximum duration of 0.5 years | Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 1 day out of every 28 in the Q4W regimen. |
| Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 and Cycle 1 Day 7 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose | Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing) | Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing) | Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 and Cycle 1 Day 7 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose | Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. |
| Phase I and II: Disease Control Rate (DCR) Per RANO | Up to 4.1 years in Phase I and 1.4 years in Phase II | DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per RANO criteria. |
| Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing) | Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. |
| Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 and Cycle 1 Day 7 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose | PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-24hr calculation. |
| Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose | PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-24hr calculation. |
| Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing) | Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose | PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation. |
| Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose | PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-24hr calculation. |
| Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (4d on/10d Off Regimen, BID Dosing) | Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose | PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation. |
| Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | pre-infusion and 1, 24, 168, 336 and 672 hours after completion of the infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The average duration of the infusion was 30 minutes. The duration of one cycle was 28 days | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | pre-infusion and 1, 24, 168, 336 and 672 hours after completion of the infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The average duration of the infusion was 30 minutes. The duration of one cycle was 28 days | Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. |
| Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | pre-infusion and 1, 24, 168, 336 and 672 hours after completion of the infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The average duration of the infusion was 30 minutes. The duration of one cycle was 28 days | PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-28day calculation. |
| Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Baseline (before first dose) and post-baseline (assessed throughout the treatment and safety follow-up, up to 4.4 years in phase I and 0.9 years in phase II). | Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-PDR001 antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample * Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample |
| Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing) | Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. |
| Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001 | PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. PFS was analyzed using Kaplan-Meier estimates. |
| Phase I: Progression-Free Survival (PFS) Per irRC | From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001 | PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per immune-related Response Criteria (irRC). PFS was analyzed using Kaplan-Meier estimates. |
| Phase I: Progression-Free Survival (PFS) Per RANO | From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001 | PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per response assessment in neuro-oncology (RANO) criteria. PFS was analyzed using Kaplan-Meier estimates. |
| Phase I and II: Progression-Free Survival (PFS) Per iRANO | From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001 | PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per immune response assessment in neuro-oncology (iRANO) criteria. PFS was analyzed using Kaplan-Meier estimates. |
| Phase I: Progression-Free Survival (PFS) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001 | PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies. PFS was analyzed using Kaplan-Meier estimates. |
| Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | From start of treatment until disease progression, assessed up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. Complete Response (CR) and Partial response (PR) had to be confirmed by a new assessment after at least 4 weeks. |
| Phase I: Best Overall Response (BOR) With Confirmation Per irRC | From start of treatment until disease progression, assessed up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001 | BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per irRC. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. Complete Response (CR) and Partial response (PR) had to be confirmed by a new assessment after at least 4 weeks. Additionally, for irRC, progressive disease had to be confirmed. |
Countries
Israel, Italy, Japan, Singapore, Spain, Switzerland, Taiwan, United States
Participant flow
Recruitment details
Participants took part in 14 investigative sites in 8 countries.
Pre-assignment details
The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 28 days prior to the first dose of study medication. After screening, the treatment period started on Cycle 1 Day 1.
Participants by arm
| Arm | Count |
|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD BLZ945 150 mg once per day administered for 7 days and suspended for 7 days | 5 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD BLZ945 300 mg once per day administered for 7 days and suspended for 7 days | 7 |
| Phase I: BLZ945 300 mg Q1W QD BLZ945 300 mg once per day once weekly | 5 |
| Phase I: BLZ945 450 mg Q1W QD BLZ945 450 mg once per day once weekly | 6 |
| Phase I: BLZ945 600 mg Q1W QD BLZ945 600 mg once per day once weekly | 3 |
| Phase I: BLZ945 1000 mg Q1W QD BLZ945 1000 mg once per day once weekly | 5 |
| Phase I: BLZ945 1600 mg Q1W QD BLZ945 1600 mg once per day once weekly | 6 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD BLZ945 300 mg once per day administered for 4 days and suspended for 10 days | 8 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD BLZ945 600 mg once per day administered for 4 days and suspended for 10 days | 9 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD BLZ945 800 mg once per day administered for 4 days and suspended for 10 days | 5 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD BLZ945 1200 mg once per day administered for 4 days and suspended for 10 days | 10 |
| Phase I: BLZ945 600 mg Q1W BID BLZ945 600 mg twice per day once weekly | 5 |
| Phase I: BLZ945 600 mg 4d on/10d Off BID BLZ945 600 mg twice per day administered for 4 days and suspended for 10 days | 6 |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W BLZ945 150 mg once per day once weekly in combination with PDR001 400 mg every 4 weeks | 4 |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W BLZ945 300 mg once per day once weekly in combination with PDR001 400 mg every 4 weeks | 5 |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W BLZ945 600 mg once per day once weekly in combination with PDR001 400 mg every 4 weeks | 9 |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W BLZ945 1000 mg once per day once weekly in combination with PDR001 400 mg every 4 weeks | 5 |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W BLZ945 1400 mg once per day once weekly in combination with PDR001 400 mg every 4 weeks | 6 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W BLZ945 300 mg once per day administered for 4 days and suspended for 10 days in combination with PDR001 400 mg every 4 weeks | 5 |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W BLZ945 450 mg once per day administered for 4 days and suspended for 10 days in combination with PDR001 400 mg every 4 weeks | 11 |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W BLZ945 700 mg once per day administered for 4 days and suspended for 10 days in combination with PDR001 400 mg every 4 weeks | 9 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W BLZ945 1200 mg once per day administered for 4 days and suspended for 10 days in combination with PDR001 400 mg every 4 weeks | 4 |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W BLZ945 600 mg twice per day once weekly in combination with PDR001 400 mg every 4 weeks | 6 |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W BLZ945 800 mg twice per day once weekly in combination with PDR001 400 mg every 4 weeks | 5 |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD BLZ945 1200 mg once per day administered for 4 days and suspended for 10 days | 22 |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W BLZ945 700 mg once per day administered for 4 days and suspended for 10 days in combination with PDR001 400 mg every 4 weeks | 21 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 0 | 0 | 1 | 1 | 3 | 5 |
| Overall Study | Death | 1 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 3 |
| Overall Study | Progressive disease | 4 | 6 | 3 | 3 | 3 | 5 | 4 | 6 | 8 | 4 | 9 | 0 | 3 | 4 | 2 | 4 | 5 | 3 | 4 | 4 | 7 | 6 | 3 | 3 | 3 | 16 | 10 |
| Overall Study | Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Subject/guardian decision | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: BLZ945 300 mg Q1W QD | Phase I: BLZ945 450 mg Q1W QD | Phase I: BLZ945 600 mg Q1W QD | Phase I: BLZ945 1000 mg Q1W QD | Phase I: BLZ945 1600 mg Q1W QD | Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: BLZ945 600 mg Q1W BID | Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 17.68 | 59.2 years STANDARD_DEVIATION 13.33 | 55.3 years STANDARD_DEVIATION 9.4 | 59.0 years STANDARD_DEVIATION 3.61 | 55.4 years STANDARD_DEVIATION 18.85 | 60.7 years STANDARD_DEVIATION 14.24 | 55.5 years STANDARD_DEVIATION 15.11 | 54.6 years STANDARD_DEVIATION 17.48 | 57.6 years STANDARD_DEVIATION 6.95 | 63.0 years STANDARD_DEVIATION 8.94 | 52.8 years STANDARD_DEVIATION 15.64 | 57.0 years STANDARD_DEVIATION 16.8 | 53.5 years STANDARD_DEVIATION 18.77 | 50.8 years STANDARD_DEVIATION 9.42 | 59.6 years STANDARD_DEVIATION 3.21 | 46.7 years STANDARD_DEVIATION 9.11 | 58.2 years STANDARD_DEVIATION 13.52 | 50.7 years STANDARD_DEVIATION 16.68 | 49.8 years STANDARD_DEVIATION 19.77 | 58.9 years STANDARD_DEVIATION 13.26 | 50.6 years STANDARD_DEVIATION 15.42 | 46.3 years STANDARD_DEVIATION 15.59 | 67.2 years STANDARD_DEVIATION 9.37 | 53.2 years STANDARD_DEVIATION 13.31 | 56.8 years STANDARD_DEVIATION 12.64 | 55.0 years STANDARD_DEVIATION 8.79 | 55.7 years STANDARD_DEVIATION 13.12 |
| Age, Customized 18 - < 65 years | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 4 Participants | 5 Participants | 4 Participants | 3 Participants | 2 Participants | 5 Participants | 5 Participants | 9 Participants | 3 Participants | 5 Participants | 3 Participants | 6 Participants | 7 Participants | 3 Participants | 1 Participants | 4 Participants | 15 Participants | 19 Participants | 138 Participants |
| Age, Customized 65 - < 85 years | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 5 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 2 Participants | 1 Participants | 5 Participants | 1 Participants | 7 Participants | 2 Participants | 54 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 3 Participants | 6 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 49 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 4 Participants | 7 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 2 Participants | 3 Participants | 4 Participants | 20 Participants | 20 Participants | 133 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 3 Participants | 0 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 3 Participants | 5 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 8 Participants | 6 Participants | 79 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 4 Participants | 2 Participants | 5 Participants | 5 Participants | 4 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 3 Participants | 7 Participants | 7 Participants | 2 Participants | 3 Participants | 2 Participants | 14 Participants | 15 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk | EG034 affected / at risk | EG035 affected / at risk | EG036 affected / at risk | EG037 affected / at risk | EG038 affected / at risk | EG039 affected / at risk | EG040 affected / at risk | EG041 affected / at risk | EG042 affected / at risk | EG043 affected / at risk | EG044 affected / at risk | EG045 affected / at risk | EG046 affected / at risk | EG047 affected / at risk | EG048 affected / at risk | EG049 affected / at risk | EG050 affected / at risk | EG051 affected / at risk | EG052 affected / at risk | EG053 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 5 | 0 / 7 | 1 / 5 | 2 / 6 | 0 / 3 | 0 / 5 | 2 / 6 | 0 / 8 | 1 / 9 | 0 / 5 | 1 / 10 | 0 / 1 | 2 / 4 | 1 / 6 | 0 / 4 | 4 / 5 | 3 / 9 | 3 / 5 | 3 / 6 | 2 / 5 | 6 / 11 | 4 / 9 | 3 / 4 | 4 / 6 | 2 / 5 | 2 / 22 | 8 / 21 | 4 / 4 | 4 / 7 | 3 / 4 | 3 / 4 | 3 / 3 | 5 / 5 | 3 / 4 | 7 / 8 | 7 / 8 | 4 / 5 | 6 / 9 | 1 / 1 | 2 / 2 | 5 / 5 | 2 / 4 | 1 / 1 | 3 / 6 | 2 / 2 | 1 / 3 | 0 / 3 | 2 / 5 | 2 / 5 | 0 / 1 | 1 / 2 | 3 / 3 | 14 / 20 | 9 / 13 |
| other Total, other adverse events | 5 / 5 | 7 / 7 | 5 / 5 | 6 / 6 | 3 / 3 | 5 / 5 | 6 / 6 | 8 / 8 | 9 / 9 | 5 / 5 | 10 / 10 | 1 / 1 | 4 / 4 | 6 / 6 | 4 / 4 | 5 / 5 | 9 / 9 | 5 / 5 | 6 / 6 | 5 / 5 | 11 / 11 | 9 / 9 | 4 / 4 | 6 / 6 | 5 / 5 | 20 / 22 | 19 / 21 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 3 / 5 | 1 / 7 | 3 / 5 | 2 / 6 | 0 / 3 | 3 / 5 | 3 / 6 | 4 / 8 | 3 / 9 | 3 / 5 | 5 / 10 | 0 / 1 | 3 / 4 | 5 / 6 | 1 / 4 | 2 / 5 | 6 / 9 | 4 / 5 | 3 / 6 | 1 / 5 | 6 / 11 | 7 / 9 | 4 / 4 | 2 / 6 | 1 / 5 | 10 / 22 | 11 / 21 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Phase I: Dose Intensity of BLZ945
Dose intensity of BLZ945 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 7 days out of every 14 in the 7 days on/7 days off regimen, 4 days out of every 14 in the 4 days on/10 days off regimen and 1 day out of every 7 in the Q1W regimen.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 3 years for BLZ945 single agent and 4 years for BLZ945 in combination with PDR001
Population: All patients from Phase I who received at least one dose of BLZ945. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Dose Intensity of BLZ945 | 141.4 mg/day | Standard Deviation 5.16 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Dose Intensity of BLZ945 | 250.1 mg/day | Standard Deviation 39.3 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Dose Intensity of BLZ945 | 281.8 mg/day | Standard Deviation 52.5 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Dose Intensity of BLZ945 | 399.2 mg/day | Standard Deviation 63.71 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Dose Intensity of BLZ945 | 525.0 mg/day | Standard Deviation 129.9 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Dose Intensity of BLZ945 | 959.5 mg/day | Standard Deviation 132.4 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Dose Intensity of BLZ945 | 1570.9 mg/day | Standard Deviation 153.93 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Dose Intensity of BLZ945 | 277.8 mg/day | Standard Deviation 25.7 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Dose Intensity of BLZ945 | 578.8 mg/day | Standard Deviation 27.27 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Dose Intensity of BLZ945 | 705.1 mg/day | Standard Deviation 98.99 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Dose Intensity of BLZ945 | 1055.0 mg/day | Standard Deviation 103.62 |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Dose Intensity of BLZ945 | 600.0 mg/day | — |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Dose Intensity of BLZ945 | 1063.1 mg/day | Standard Deviation 321.62 |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Dose Intensity of BLZ945 | 1105.5 mg/day | Standard Deviation 71.77 |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 160.0 mg/day | Standard Deviation 14.14 |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 293.5 mg/day | Standard Deviation 14.5 |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 566.3 mg/day | Standard Deviation 51.79 |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 945.7 mg/day | Standard Deviation 87.13 |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 1259.0 mg/day | Standard Deviation 209.04 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 286.0 mg/day | Standard Deviation 18.49 |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 416.1 mg/day | Standard Deviation 32.3 |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 606.9 mg/day | Standard Deviation 56.03 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 862.0 mg/day | Standard Deviation 243.73 |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 1125.1 mg/day | Standard Deviation 224.13 |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Dose Intensity of BLZ945 | 1448.0 mg/day | Standard Deviation 386.16 |
Primary
Phase I: Dose Intensity of PDR001
Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 1 day out of every 28 in the Q4W regimen.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 4 years
Population: All patients from Phase I who received at least one dose of PDR001. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Dose Intensity of PDR001 | 533.3 mg/day | Standard Deviation 188.56 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Dose Intensity of PDR001 | 400.0 mg/day | Standard Deviation 0 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Dose Intensity of PDR001 | 400.0 mg/day | Standard Deviation 0 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Dose Intensity of PDR001 | 426.7 mg/day | Standard Deviation 59.63 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Dose Intensity of PDR001 | 433.3 mg/day | Standard Deviation 81.65 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Dose Intensity of PDR001 | 420.0 mg/day | Standard Deviation 44.72 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Dose Intensity of PDR001 | 390.5 mg/day | Standard Deviation 31.46 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Dose Intensity of PDR001 | 393.1 mg/day | Standard Deviation 14.05 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Dose Intensity of PDR001 | 400.0 mg/day | Standard Deviation 0 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Dose Intensity of PDR001 | 466.7 mg/day | Standard Deviation 163.3 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Dose Intensity of PDR001 | 453.3 mg/day | Standard Deviation 202.21 |
Primary
Phase II: Progression-Free Survival Rate at 6 Months (PFS6) Per RANO Criteria for Glioblastoma
PFS rate represents the percentage of participants without a first documented progression or death due to any cause after the start of study treatment. Tumor response was based on local investigator assessment per Response Assessment in Neuro Oncology (RANO) criteria. PFS was analyzed using Kaplan-Meier estimates.
Time frame: 6 months
Population: All patients from Phase II who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Progression-Free Survival Rate at 6 Months (PFS6) Per RANO Criteria for Glioblastoma | 15.2 percentage of participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Progression-Free Survival Rate at 6 Months (PFS6) Per RANO Criteria for Glioblastoma | 22.2 percentage of participants |
Primary
Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
Time frame: From first dose of study medication up to 30 days after last dose, with a maximum duration of 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 3 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 7 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 7 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 2 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 1 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 3 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 3 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 6 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 8 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 9 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 8 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 7 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 10 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 5 Participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 4 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 5 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 6 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 4 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 2 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 5 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 9 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 2 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 7 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 3 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 1 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 5 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 8 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 11 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 9 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 1 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 2 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 7 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 4 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 3 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 4 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 6 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 5 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 2 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 1 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 5 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 4 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 1 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
Primary
Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Japanese Cohort)
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with BLZ945 as single agent or in combination with PDR001 during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Time frame: 28 days
Population: Japanese patients in Phase I who either met the minimum exposure criterion defined in the protocol and had sufficient safety evaluations, or had experienced a DLT during Cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Japanese Cohort) | 1 Participants |
Primary
Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort)
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with BLZ945 as single agent or in combination with PDR001 during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Time frame: 28 days
Population: Non-Japanese patients in Phase I who either met the minimum exposure criterion defined in the protocol and had sufficient safety evaluations, or had experienced a DLT during Cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 2 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 2 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose-Limiting Toxicities (DLTs) (Non-Japanese Cohort) | 2 Participants |
Primary
Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945
Number of participants with at least one dose reduction of BLZ945 and number of participants with at least one dose interruption of BLZ945.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 3 years for BLZ945 single agent and 4 years for BLZ945 in combination with PDR001
Population: All patients from Phase I who received at least one dose of BLZ945. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 4 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 2 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 3 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 3 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 5 Participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 4 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 3 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 4 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 6 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 2 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 1 Participants |
Primary
Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001
Number of participants with at least one dose reduction of PDR001 and number of participants with at least one dose interruption of PDR001. Dose reductions were not permitted for PDR001.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 4 years
Population: All patients from Phase I who received at least one dose of PDR001. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 3 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 1 Participants |
Secondary
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (4d on/10d Off Regimen, BID Dosing)
PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (4d on/10d off regimen, BID dosing) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495. Patients treated at the same dose level and regimen are pooled together.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (4d on/10d Off Regimen, BID Dosing) | Cycle 1 Day 1 | 123 hr*µg/mL | Standard Deviation 31.4 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (4d on/10d Off Regimen, BID Dosing) | Cycle 1 Day 4 | 235 hr*µg/mL | Standard Deviation 51.9 |
Secondary
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing)
PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (Q1W regimen, BID dosing) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing) | Cycle 1 Day 1 | 127 hr*µg/mL | Standard Deviation 38.8 |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing) | Cycle 1 Day 1 | 119 hr*µg/mL | Standard Deviation 1.69 |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing) | Cycle 1 Day 8 | 142 hr*µg/mL | Standard Deviation 30.4 |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing) | Cycle 1 Day 1 | 159 hr*µg/mL | Standard Deviation 27.2 |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing) | Cycle 1 Day 8 | 165 hr*µg/mL | — |
Secondary
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing)
PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-24hr calculation.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (4d on/10d off regimen, QD dosing) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495. Patients treated at the same dose level and regimen are pooled together.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 117 hr*µg/mL | Standard Deviation 26.7 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 212 hr*µg/mL | Standard Deviation 71.7 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 268 hr*µg/mL | Standard Deviation 32.2 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 444 hr*µg/mL | Standard Deviation 88.6 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 241 hr*µg/mL | Standard Deviation 74.2 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 418 hr*µg/mL | Standard Deviation 73.1 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 371 hr*µg/mL | Standard Deviation 88.6 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 653 hr*µg/mL | Standard Deviation 189 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 138 hr*µg/mL | Standard Deviation 39.2 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 197 hr*µg/mL | Standard Deviation 95.6 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 165 hr*µg/mL | Standard Deviation 54.1 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 301 hr*µg/mL | Standard Deviation 124 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 431 hr*µg/mL | Standard Deviation 156 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 231 hr*µg/mL | Standard Deviation 62.2 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 1 | 424 hr*µg/mL | Standard Deviation 87.9 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing) | Cycle 1 Day 4 | 656 hr*µg/mL | Standard Deviation 224 |
Secondary
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (7d on/7d Off Regimen)
PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-24hr calculation.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (7d on/7d off regimen) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 | 56.2 hr*µg/mL | Standard Deviation 9.43 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 7 | 89.8 hr*µg/mL | Standard Deviation 35.9 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 | 125 hr*µg/mL | Standard Deviation 30.8 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 7 | 226 hr*µg/mL | Standard Deviation 72.1 |
Secondary
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing)
PK parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-24hr calculation.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (Q1W regimen, QD dosing) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 118 hr*µg/mL | Standard Deviation 17.3 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 136 hr*µg/mL | Standard Deviation 31.9 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 187 hr*µg/mL | Standard Deviation 43.3 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 182 hr*µg/mL | Standard Deviation 71.9 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 211 hr*µg/mL | Standard Deviation 44.1 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 226 hr*µg/mL | Standard Deviation 48.5 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 326 hr*µg/mL | Standard Deviation 39.9 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 422 hr*µg/mL | Standard Deviation 95 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 481 hr*µg/mL | Standard Deviation 126 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 399 hr*µg/mL | Standard Deviation 48.1 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 69.4 hr*µg/mL | Standard Deviation 8.67 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 51.6 hr*µg/mL | Standard Deviation 20.8 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 120 hr*µg/mL | Standard Deviation 27.7 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 118 hr*µg/mL | Standard Deviation 27 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 218 hr*µg/mL | Standard Deviation 19.5 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 233 hr*µg/mL | Standard Deviation 37.3 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 290 hr*µg/mL | Standard Deviation 20.5 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 323 hr*µg/mL | Standard Deviation 105 |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 1 | 410 hr*µg/mL | Standard Deviation 76 |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (Q1W Regimen, QD Dosing) | Cycle 1 Day 8 | 486 hr*µg/mL | Standard Deviation 118 |
Secondary
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001
PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-28day calculation.
Time frame: pre-infusion and 1, 24, 168, 336 and 672 hours after completion of the infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The average duration of the infusion was 30 minutes. The duration of one cycle was 28 days
Population: Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495. Patients treated at the same dose level and regimen are pooled together.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1390 day*µg/mL | Standard Deviation 250 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 1960 day*µg/mL | Standard Deviation 297 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 1780 day*µg/mL | — |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1120 day*µg/mL | Standard Deviation 203 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1160 day*µg/mL | Standard Deviation 228 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 1930 day*µg/mL | Standard Deviation 630 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1130 day*µg/mL | Standard Deviation 274 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 1480 day*µg/mL | — |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 1240 day*µg/mL | — |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1310 day*µg/mL | Standard Deviation 301 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1350 day*µg/mL | Standard Deviation 468 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 1750 day*µg/mL | Standard Deviation 838 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1270 day*µg/mL | Standard Deviation 204 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 2350 day*µg/mL | Standard Deviation 439 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 3 Day 1 | 1950 day*µg/mL | Standard Deviation 1220 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1230 day*µg/mL | Standard Deviation 308 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001 | Cycle 1 Day 1 | 1330 day*µg/mL | Standard Deviation 183 |
Secondary
Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO
BOR is defined as the best response recorded from the start of the study treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started), based on local investigator assessment per iRANO. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. If a response recorded at one scheduled magnetic resonance imaging (MRI) did not persist at the next regular scheduled MRI, the response was recorded based on the prior scan, but was designated as a non-sustained response. If the response was sustained, i.e. still present on the subsequent MRI, it was recorded as a sustained response, lasting until the time of tumor progression. CR and PR had to be confirmed by repeat assessments performed not less than 4 weeks after the criteria for response were first met. Additionally, for iRANO, progressive disease had to be confirmed.
Time frame: From start of treatment until disease progression, assessed up to 4.1 years in Phase I and 1.4 years in Phase II
Population: All patients with glioblastoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 1 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 2 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 2 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 3 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 2 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 1 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 1 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 2 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 3 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 1 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 15 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 3 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Stable Disease (SD) | 5 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Complete Response (CR) | 0 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Partial Response (PR) | 0 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Unknown | 16 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per iRANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
Secondary
Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO
BOR is defined as the best response recorded from the start of the study treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started), based on local investigator assessment per RANO criteria. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. If a response recorded at one scheduled magnetic resonance imaging (MRI) did not persist at the next regular scheduled MRI, the response was recorded based on the prior scan, but was designated as a non-sustained response. If the response was sustained, i.e. still present on the subsequent MRI, it was recorded as a sustained response, lasting until the time of tumor progression. CR and PR had to be confirmed by repeat assessments performed not less than 4 weeks after the criteria for response were first met.
Time frame: From start of treatment until disease progression, assessed up to 4.1 years in Phase I and 1.4 years in Phase II
Population: All patients with glioblastoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 1 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 2 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 1 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 3 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 2 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 1 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 1 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 1 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 10 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 3 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 4 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 2 Participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 3 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per tumor assessment | 11 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Unknown | 4 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Complete Response (CR) | 0 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Progressive Disease (PD) as per clinical assessment | 1 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Partial Response (PR) | 0 Participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Best Overall Response (BOR) (Sustained) Per RANO | Stable Disease (SD) | 5 Participants |
Secondary
Phase I and II: Disease Control Rate (DCR) Per iRANO
DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per iRANO criteria.
Time frame: Up to 4.1 years in Phase I and 1.4 years in Phase II
Population: All patients with glioblastoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Disease Control Rate (DCR) Per iRANO | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Disease Control Rate (DCR) Per iRANO | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Disease Control Rate (DCR) Per iRANO | 33.3 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Disease Control Rate (DCR) Per iRANO | 50.0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Disease Control Rate (DCR) Per iRANO | 33.3 percentage of participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per iRANO | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per iRANO | 100 percentage of participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per iRANO | 40.0 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per iRANO | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per iRANO | 0 percentage of participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per iRANO | 0 percentage of participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Disease Control Rate (DCR) Per iRANO | 27.3 percentage of participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per iRANO | 23.8 percentage of participants |
Secondary
Phase I and II: Disease Control Rate (DCR) Per RANO
DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per RANO criteria.
Time frame: Up to 4.1 years in Phase I and 1.4 years in Phase II
Population: All patients with glioblastoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Disease Control Rate (DCR) Per RANO | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Disease Control Rate (DCR) Per RANO | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Disease Control Rate (DCR) Per RANO | 33.3 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Disease Control Rate (DCR) Per RANO | 50.0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Disease Control Rate (DCR) Per RANO | 33.3 percentage of participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per RANO | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per RANO | 100 percentage of participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per RANO | 40.0 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per RANO | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per RANO | 0 percentage of participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per RANO | 0 percentage of participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Disease Control Rate (DCR) Per RANO | 27.3 percentage of participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Disease Control Rate (DCR) Per RANO | 23.8 percentage of participants |
Secondary
Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen)
Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing)
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (4d on/10d off regimen) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495. Patients treated at the same dose level and regimen are pooled together.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 14.4 µg/mL | Standard Deviation 4.4 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 9.59 µg/mL | Standard Deviation 2.86 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 18.2 µg/mL | Standard Deviation 3.44 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 28.1 µg/mL | Standard Deviation 4.26 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 23.6 µg/mL | Standard Deviation 6.78 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 16.2 µg/mL | Standard Deviation 5.15 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 24.5 µg/mL | Standard Deviation 5.79 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 38.2 µg/mL | Standard Deviation 10.1 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 16.5 µg/mL | Standard Deviation 3.06 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 30.5 µg/mL | Standard Deviation 5.65 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 14.1 µg/mL | Standard Deviation 3.29 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 9.31 µg/mL | Standard Deviation 3.47 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 11.8 µg/mL | Standard Deviation 3.35 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 19.3 µg/mL | Standard Deviation 7.53 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 16.7 µg/mL | Standard Deviation 4.45 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 26 µg/mL | Standard Deviation 8.54 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 40.3 µg/mL | Standard Deviation 11.9 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 25 µg/mL | Standard Deviation 5.4 |
Secondary
Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (7d on/7d Off Regimen)
Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (7d on/7d off regimen) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 | 4.48 µg/mL | Standard Deviation 1.42 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 7 | 6.58 µg/mL | Standard Deviation 2.07 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 | 9.33 µg/mL | Standard Deviation 2.8 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 7 | 13.9 µg/mL | Standard Deviation 4.51 |
Secondary
Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen)
Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing)
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (Q1W regimen) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 8.39 µg/mL | Standard Deviation 1.39 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 8.74 µg/mL | Standard Deviation 1.84 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 13.2 µg/mL | Standard Deviation 4.81 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 15.4 µg/mL | Standard Deviation 3.04 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 15.8 µg/mL | Standard Deviation 3.18 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 13 µg/mL | Standard Deviation 3.42 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 20.1 µg/mL | Standard Deviation 3.07 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 27.1 µg/mL | Standard Deviation 3.3 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 26.4 µg/mL | Standard Deviation 6.42 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 29.6 µg/mL | Standard Deviation 7.22 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 15 µg/mL | Standard Deviation 3.04 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 13.6 µg/mL | Standard Deviation 3.64 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 3.94 µg/mL | Standard Deviation 0.847 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 4.68 µg/mL | Standard Deviation 0.731 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 9.02 µg/mL | Standard Deviation 2.14 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 9.05 µg/mL | Standard Deviation 2.94 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 17.3 µg/mL | Standard Deviation 2.44 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 16.5 µg/mL | Standard Deviation 2.97 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 18.9 µg/mL | Standard Deviation 2.09 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 20.6 µg/mL | Standard Deviation 4.89 |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 33.9 µg/mL | Standard Deviation 6.92 |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 25.3 µg/mL | Standard Deviation 4.84 |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 15.5 µg/mL | Standard Deviation 3.13 |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 16.4 µg/mL | Standard Deviation 3.83 |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 17.6 µg/mL | Standard Deviation 3.12 |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Maximum Observed Serum Concentration (Cmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 16.4 µg/mL | Standard Deviation 3.66 |
Secondary
Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time frame: pre-infusion and 1, 24, 168, 336 and 672 hours after completion of the infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The average duration of the infusion was 30 minutes. The duration of one cycle was 28 days
Population: Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495. Patients treated at the same dose level and regimen are pooled together.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 120 µg/mL | Standard Deviation 42.3 |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 102 µg/mL | Standard Deviation 13.6 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 93.8 µg/mL | Standard Deviation 26.3 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 132 µg/mL | Standard Deviation 16.1 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 102 µg/mL | Standard Deviation 20.9 |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 142 µg/mL | Standard Deviation 38.1 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 96.3 µg/mL | Standard Deviation 25.7 |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 114 µg/mL | Standard Deviation 40.4 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 138 µg/mL | Standard Deviation 54.2 |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 111 µg/mL | Standard Deviation 25.2 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 137 µg/mL | Standard Deviation 55.4 |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 102 µg/mL | Standard Deviation 10.5 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 156 µg/mL | Standard Deviation 48.5 |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 102 µg/mL | Standard Deviation 19.4 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 99.4 µg/mL | Standard Deviation 27.6 |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 126 µg/mL | Standard Deviation 55.6 |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 122 µg/mL | Standard Deviation 5.35 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 3 Day 1 | 118 µg/mL | Standard Deviation 44.3 |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 111 µg/mL | Standard Deviation 25.1 |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Maximum Observed Serum Concentration (Cmax) of PDR001 | Cycle 1 Day 1 | 102 µg/mL | Standard Deviation 28 |
Secondary
Phase I and II: Number of Participants With Anti-PDR001 Antibodies
Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-PDR001 antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample * Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
Time frame: Baseline (before first dose) and post-baseline (assessed throughout the treatment and safety follow-up, up to 4.4 years in phase I and 0.9 years in phase II).
Population: All patients who received at least one full or partial dose of the combination BLZ945+PDR001 and had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample for assessing anti-PDR001 antibodies. Determinant samples are defined as samples which are not unevaluable (where unevaluable = sample where assay is not available).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 3 participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 3 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 5 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 5 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 5 participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 1 participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 1 participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 4 participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 1 participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 4 participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 4 participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 6 participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 6 participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 1 participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 4 participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 4 participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 10 participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 8 participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 2 participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 7 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 7 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 4 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 4 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 5 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 5 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 4 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 4 participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-boosted ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative at baseline | 17 participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | Treatment-induced ADA-positive | 0 participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-positive at baseline | 0 participants |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Number of Participants With Anti-PDR001 Antibodies | ADA-negative post-baseline | 17 participants |
Secondary
Phase I and II: Progression-Free Survival (PFS) Per iRANO
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per immune response assessment in neuro-oncology (iRANO) criteria. PFS was analyzed using Kaplan-Meier estimates.
Time frame: From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001
Population: All patients with glioblastoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Progression-Free Survival (PFS) Per iRANO | NA months |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Progression-Free Survival (PFS) Per iRANO | NA months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Progression-Free Survival (PFS) Per iRANO | NA months |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Progression-Free Survival (PFS) Per iRANO | NA months |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Progression-Free Survival (PFS) Per iRANO | NA months |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I and II: Progression-Free Survival (PFS) Per iRANO | 2.2 months |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Progression-Free Survival (PFS) Per iRANO | NA months |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Progression-Free Survival (PFS) Per iRANO | 12.0 months |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Progression-Free Survival (PFS) Per iRANO | 1.2 months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Progression-Free Survival (PFS) Per iRANO | NA months |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I and II: Progression-Free Survival (PFS) Per iRANO | 3.2 months |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Progression-Free Survival (PFS) Per iRANO | 6.7 months |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I and II: Progression-Free Survival (PFS) Per iRANO | 3.0 months |
Secondary
Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen)
Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 4 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing)
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (4d on/10d off regimen) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495. Patients treated at the same dose level and regimen are pooled together.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 1.54 hours |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 1.05 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 2 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 2.03 hours |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 2.07 hours |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 4 hours |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 2.06 hours |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 2.04 hours |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 0.933 hours |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 1.93 hours |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 2.02 hours |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 1.95 hours |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 1.95 hours |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 2 hours |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 2 hours |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 1.92 hours |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 1 | 3 hours |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (4d on/10d Off Regimen) | Cycle 1 Day 4 | 4 hours |
Secondary
Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (7d on/7d Off Regimen)
Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (7d on/7d off regimen) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 | 1.29 hours |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 7 | 1 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 1 | 1.88 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (7d on/7d Off Regimen) | Cycle 1 Day 7 | 2.03 hours |
Secondary
Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen)
Pharmacokinetic (PK) parameters were calculated based on BLZ945 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time frame: Cycle 1 Day 1 and Cycle 1 Day 8 (1 cycle=28 days): pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose (QD dosing); pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post morning dose (and pre evening dose) and 12 hours post evening dose (BID dosing)
Population: Patients in the pharmacokinetic analysis set (PAS) who received BLZ945 (Q1W regimen) and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 2.03 hours |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 1.88 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 1.9 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 1.53 hours |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 3.83 hours |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 2 hours |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 2.07 hours |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 4.07 hours |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 3 hours |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 3.82 hours |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 2.12 hours |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 2.17 hours |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 1.43 hours |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 1.9 hours |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 1.17 hours |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 1.03 hours |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 1.78 hours |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 1.98 hours |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 1.02 hours |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 2.1 hours |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 2.07 hours |
| Phase I: BLZ945 300 mg Q1W BID | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 2.43 hours |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 1.88 hours |
| Phase I: BLZ945 600 mg Q1W BID | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 2.05 hours |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 8 | 7.1 hours |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of BLZ945 (Q1W Regimen) | Cycle 1 Day 1 | 1.8 hours |
Secondary
Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time frame: pre-infusion and 1, 24, 168, 336 and 672 hours after completion of the infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The average duration of the infusion was 30 minutes. The duration of one cycle was 28 days
Population: Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one primary PK parameter and did not vomit within 4 hours after dosing with BLZ495. Patients treated at the same dose level and regimen are pooled together.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.67 hours |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 1.48 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 1.45 hours |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.45 hours |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 1.58 hours |
| Phase I: BLZ945 300 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.5 hours |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.28 hours |
| Phase I: BLZ945 450 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 1.81 hours |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.48 hours |
| Phase I: BLZ945 600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 13 hours |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 1.53 hours |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.42 hours |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 1.53 hours |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.48 hours |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.79 hours |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 12.7 hours |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.46 hours |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 3 Day 1 | 94.4 hours |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.53 hours |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I and II: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | Cycle 1 Day 1 | 1.55 hours |
Secondary
Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation.
Time frame: From start of treatment until disease progression, assessed up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with lymphoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Partial response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Progressive Disease (PD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Stable disease (SD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Unknown | 2 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Unknown | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Partial response (PR) | 1 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Stable disease (SD) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | Progressive Disease (PD) | 1 Participants |
Secondary
Phase I: Best Overall Response (BOR) With Confirmation Per irRC
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per irRC. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. Complete Response (CR) and Partial response (PR) had to be confirmed by a new assessment after at least 4 weeks. Additionally, for irRC, progressive disease had to be confirmed.
Time frame: From start of treatment until disease progression, assessed up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 3 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 1 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 1 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 6 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 4 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 1 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 0 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 2 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 4 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 2 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 4 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 4 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 4 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 3 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 4 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 1 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 1 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 3 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 1 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 3 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 1 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 4 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 2 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 3 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 2 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Complete Response (irCR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Partial Response (irPR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Progressive Disease (irPD) | 2 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Stable Disease (irSD) | 1 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per irRC | Unknown | 0 Participants |
Secondary
Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1
BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1. However, any assessments taken more than 30 days after the last dose of study therapy were not included in the best overall response derivation. Complete Response (CR) and Partial response (PR) had to be confirmed by a new assessment after at least 4 weeks.
Time frame: From start of treatment until disease progression, assessed up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 1 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 6 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 0 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 2 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 4 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 2 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 4 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 2 Participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 1 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 3 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 1 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 1 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 3 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 2 Participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 4 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 2 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 4 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Non-CR/Non-PD (NCRNPD) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Complete Response (CR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Partial Response (PR) | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Unknown | 0 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Progressive Disease (PD) | 2 Participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Best Overall Response (BOR) With Confirmation Per RECIST v1.1 | Stable Disease (SD) | 1 Participants |
Secondary
Phase I: Disease Control Rate (DCR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies
DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies.
Time frame: Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with lymphoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | 0 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | 50.0 percentage of participants |
Secondary
Phase I: Disease Control Rate (DCR) Per irRC
DCR is the percentage of patients with a best overall response of complete response (irCR), partial response (irPR) or stable disease (irSD), based on local investigator assessment per irRC.
Time frame: Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Disease Control Rate (DCR) Per irRC | 60.0 percentage of participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Disease Control Rate (DCR) Per irRC | 14.3 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per irRC | 20.0 percentage of participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per irRC | 66.7 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per irRC | 40.0 percentage of participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per irRC | 50.0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per irRC | 37.5 percentage of participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per irRC | 40.0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per irRC | 28.6 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Disease Control Rate (DCR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Disease Control Rate (DCR) Per irRC | 33.3 percentage of participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 75.0 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 40.0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 57.1 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 20.0 percentage of participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 40.0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 50.0 percentage of participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 33.3 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 100 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 33.3 percentage of participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per irRC | 33.3 percentage of participants |
Secondary
Phase I: Disease Control Rate (DCR) Per RECIST v1.1
DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per RECIST v1.1.
Time frame: Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 60.0 percentage of participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 14.3 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 20.0 percentage of participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 66.7 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 40.0 percentage of participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 50.0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 37.5 percentage of participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 40.0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 28.6 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 33.3 percentage of participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 75.0 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 40.0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 57.1 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 20.0 percentage of participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 40.0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 50.0 percentage of participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 33.3 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 100 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 16.7 percentage of participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Disease Control Rate (DCR) Per RECIST v1.1 | 33.3 percentage of participants |
Secondary
Phase II: Dose Intensity of BLZ945
Dose intensity of BLZ945 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 4 days out of every 14 in the 4 days on/10 days off regimen.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 1.3 years for BLZ945 single agent and 0.5 years for BLZ945 in combination with PDR001
Population: All patients from Phase II who received at least one dose of BLZ945. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Dose Intensity of BLZ945 | 1104.7 mg/day | Standard Deviation 119.63 |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Dose Intensity of BLZ945 | 610.4 mg/day | Standard Deviation 83 |
Secondary
Phase II: Dose Intensity of PDR001
Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by the number of dose days scheduled per protocol during the treatment period. The denominator was calculated considering that patients received doses 1 day out of every 28 in the Q4W regimen.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 0.5 years
Population: All patients from Phase I who received at least one dose of PDR001. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Dose Intensity of PDR001 | 395.2 mg/day | Standard Deviation 21.82 |
Secondary
Phase II: Duration of Response (DOR) Per iRANO
DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per iRANO. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.
Time frame: Up to 1.4 years for BLZ945 single agent and 0.6 years for BLZ945 in combination with PDR001
Population: All patients from Phase II for whom best overall response is complete response (CR) or partial response (PR) per iRANO
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Duration of Response (DOR) Per iRANO | 16.2 months |
Secondary
Phase II: Duration of Response (DOR) Per RANO
DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RANO. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.
Time frame: Up to 1.4 years for BLZ945 single agent and 0.6 years for BLZ945 in combination with PDR001
Population: All patients from Phase II for whom best overall response is complete response (CR) or partial response (PR) per RANO
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Duration of Response (DOR) Per RANO | 7.3 months |
Secondary
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
Time frame: From first dose of study medication up to 30 days after last dose, with a maximum duration of 1.4 years for BLZ945 single agent and 0.6 years for BLZ945 in combination with PDR001
Population: All patients from Phase II who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 14 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 2 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 10 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 0 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 22 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Fatal SAEs | 1 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | AEs | 20 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related AEs | 14 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | SAEs | 10 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period | Treatment-related SAEs | 4 Participants |
Secondary
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945
Number of participants with at least one dose reduction of BLZ945 and number of participants with at least one dose interruption of BLZ945.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 1.3 years for BLZ945 single agent and 0.5 years for BLZ945 in combination with PDR001
Population: All patients from Phase II who received at least one dose of BLZ945. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 7 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose reduction | 1 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of BLZ945 | At least one dose interruption | 5 Participants |
Secondary
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of PDR001
Number of participants with at least one dose reduction of PDR001 and number of participants with at least one dose interruption of PDR001. Dose reductions were not permitted for PDR001.
Time frame: From first dose of study medication up to last dose, with a maximum duration of 0.5 years
Population: All patients from Phase I who received at least one dose of PDR001. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose reduction | 0 Participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Number of Participants With Dose Reductions and Dose Interruptions of PDR001 | At least one dose interruption | 1 Participants |
Secondary
Phase II: Overall Survival (OS)
OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, OS time was censored at the date of last contact. OS was estimated using Kaplan-Meier estimates.
Time frame: From start of treatment until death due to any cause, assessed up to 1.9 years for BLZ945 single agent and 1.3 years for BLZ945 in combination with PDR001
Population: All patients from Phase II who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase II: Overall Survival (OS) | 8.4 months |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase II: Overall Survival (OS) | 7.0 months |
Secondary
Phase I: Overall Response Rate (ORR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies
ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies.
Time frame: Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with lymphoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | 0 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | 50.0 percentage of participants |
Secondary
Phase I: Overall Response Rate (ORR) Per irRC
ORR is the percentage of patients with a best overall response of complete response (irCR) or partial response (irPR), based on local investigator assessment per irRC.
Time frame: Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 14.3 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per irRC | 0 percentage of participants |
Secondary
Phase I: Overall Response Rate (ORR) Per RECIST v1.1
ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1.
Time frame: Up to 3.1 years for BLZ945 single agent and 4.1 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 14.3 percentage of participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Overall Response Rate (ORR) Per RECIST v1.1 | 0 percentage of participants |
Secondary
Phase I: Progression-Free Survival (PFS) Per Guidelines for Efficacy Evaluation in Lymphoma Studies
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per guidelines for efficacy evaluation in lymphoma studies. PFS was analyzed using Kaplan-Meier estimates.
Time frame: From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with lymphoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | NA months |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per Guidelines for Efficacy Evaluation in Lymphoma Studies | 2.2 months |
Secondary
Phase I: Progression-Free Survival (PFS) Per irRC
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per immune-related Response Criteria (irRC). PFS was analyzed using Kaplan-Meier estimates.
Time frame: From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per irRC | 1.9 months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | 7.9 months |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | 3.5 months |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | 40.1 months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | 2.6 months |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per irRC | NA months |
Secondary
Phase I: Progression-Free Survival (PFS) Per RANO
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per response assessment in neuro-oncology (RANO) criteria. PFS was analyzed using Kaplan-Meier estimates.
Time frame: From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with glioblastoma who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per RANO | 1.9 months |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per RANO | 0.2 months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per RANO | 1.9 months |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Progression-Free Survival (PFS) Per RANO | 2.8 months |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Progression-Free Survival (PFS) Per RANO | 1.9 months |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RANO | 1.9 months |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RANO | 3.6 months |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RANO | 1.9 months |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RANO | 0.7 months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RANO | 0.8 months |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RANO | 1.1 months |
Secondary
Phase I: Progression-Free Survival (PFS) Per RECIST v1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. PFS was analyzed using Kaplan-Meier estimates.
Time frame: From start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for BLZ945 single agent and 4.4 years for BLZ945 in combination with PDR001
Population: All patients from Phase I with solid tumors (excluding glioblastoma and lymphoma) who received at least one dose of BLZ945 or PDR001. Patients were analyzed according to the planned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 300 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 450 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 600 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 1000 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 1600 mg Q1W QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | 1.9 months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 600 mg Q1W BID | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | 7.9 months |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | 3.5 months |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | 40.1 months |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | Phase I: Progression-Free Survival (PFS) Per RECIST v1.1 | NA months |
Post Hoc
All-Collected Deaths
On-treatment and post-treatment safety follow-up deaths were collected from first dose of study medication to 30 days after last dose (BLZ945 single agent; SA) and to 150 days after last dose (BLZ945+PDR001; combo). Survival follow-up deaths were collected from 31 days (SA) and 151 days (combo) after last dose until end of study. All deaths refer to the sum of on-treatment and post-treatment safety follow-up deaths plus survival follow-up deaths.
Time frame: On&post-treatment safety: up to 3.1 years (phase I)/1.4 years (phase II) for SA and 4.4 years (phase I)/0.9 years (phase II) for combo. Survival: up to 3.1 years (phase I)/1.9 years (phase II) for SA and 4.4 years (phase I)/1.3 years (phase II) for combo
Population: All patients who received at least one dose of assigned single agent BLZ945, or at least one full or partial dose of assigned combination BLZ945+PDR001. Patients were analyzed according to the study treatment (regimen) they actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I: BLZ945 150 mg 7d on/7d Off QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | All-Collected Deaths | Survival follow-up deaths | 4 participants |
| Phase I: BLZ945 150 mg 7d on/7d Off QD | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | All-Collected Deaths | Survival follow-up deaths | 4 participants |
| Phase I: BLZ945 300 mg 7d on/7d Off QD | All-Collected Deaths | All deaths | 4 participants |
| Phase I: BLZ945 300 mg Q1W QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase I: BLZ945 300 mg Q1W QD | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I: BLZ945 300 mg Q1W QD | All-Collected Deaths | All deaths | 4 participants |
| Phase I: BLZ945 450 mg Q1W QD | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I: BLZ945 450 mg Q1W QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase I: BLZ945 450 mg Q1W QD | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 600 mg Q1W QD | All-Collected Deaths | All deaths | 3 participants |
| Phase I: BLZ945 600 mg Q1W QD | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I: BLZ945 600 mg Q1W QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase I: BLZ945 1000 mg Q1W QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase I: BLZ945 1000 mg Q1W QD | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 1000 mg Q1W QD | All-Collected Deaths | Survival follow-up deaths | 5 participants |
| Phase I: BLZ945 1600 mg Q1W QD | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I: BLZ945 1600 mg Q1W QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase I: BLZ945 1600 mg Q1W QD | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | All-Collected Deaths | Survival follow-up deaths | 7 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD | All-Collected Deaths | All deaths | 7 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | All-Collected Deaths | Survival follow-up deaths | 7 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off QD | All-Collected Deaths | All deaths | 8 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | All-Collected Deaths | Survival follow-up deaths | 4 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase I: BLZ945 800 mg 4d on/10d Off QD | All-Collected Deaths | All deaths | 4 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | All-Collected Deaths | Survival follow-up deaths | 6 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD | All-Collected Deaths | All deaths | 7 participants |
| Phase I: BLZ945 300 mg Q1W BID | All-Collected Deaths | All deaths | 1 participants |
| Phase I: BLZ945 300 mg Q1W BID | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I: BLZ945 300 mg Q1W BID | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase I: BLZ945 600 mg Q1W BID | All-Collected Deaths | All deaths | 4 participants |
| Phase I: BLZ945 600 mg Q1W BID | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase I: BLZ945 600 mg Q1W BID | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | All-Collected Deaths | All deaths | 6 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 1 participants |
| Phase I: BLZ945 600 mg 4d on/10d Off BID | All-Collected Deaths | Survival follow-up deaths | 5 participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 2 participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase I: BLZ945 150 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 0 participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I: BLZ945 300 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I: BLZ945 600 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 6 participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase I: BLZ945 1000 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 4 participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I: BLZ945 1400 mg Q1W QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 2 participants |
| Phase I: BLZ945 300 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 0 participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 6 participants |
| Phase I: BLZ945 450 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 8 participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 6 participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 2 participants |
| Phase I: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 0 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 3 participants |
| Phase I: BLZ945 1200 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 3 participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 4 participants |
| Phase I: BLZ945 600 mg Q1W BID + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 1 participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 3 participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 5 participants |
| Phase I: BLZ945 800 mg Q1W BID + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 2 participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | All-Collected Deaths | Survival follow-up deaths | 14 participants |
| Phase II: BLZ945 1200 mg 4d on/10d Off QD | All-Collected Deaths | All deaths | 16 participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | All deaths | 17 participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | On-treatment and post-treatment safety follow-up deaths | 8 participants |
| Phase II: BLZ945 700 mg 4d on/10d Off QD + PDR001 400 mg Q4W | All-Collected Deaths | Survival follow-up deaths | 9 participants |